AMBULATORY HEALTH CARE ACCREDITATION (Revised on March 23, 2012) CURRENT LAWS AND REGULATIONS (Recent changes in bold)

Transcription

1 AMBULATORY HEALTH CARE ACCREDITATION (Revised on March 23, 2012) CURRENT LAWS AND REGULATIONS (Recent changes in bold) STATE STATUTE/RULE ENTITY AGENCY DESCRIPTION Alabama Chapter 540-X-10, Rules of the Alabama Board of Medical Examiners Office- based surgery Alabama Board of Medical Examiners The Board approved regulations effective on Nov. 21, 2003, encouraging accreditation of facilities where deep sedation/analgesia or general anesthesia is provided. The rules require registration and reporting, in addition to standards based on level of anesthesia provided. Arizona Az. Rev. Stat., Sec (C). Health care institutions including ambulatory surgery Services, Division of Assurance and Licensure Services The Department accepts accreditation reports from recognized entities such as AAAHC in lieu of licensing inspections. Az. Rev. Stat., Sec (3). Az. Admin. Code R Physician offices Physician offices and clinics are exempt from the licensing requirements applicable to health care institutions unless patients are kept overnight as bed patients or treated otherwise under general anesthesia, except where treatment by general anesthesia is regulated under the dentistry statutes. Office-based surgery Arizona Medical Board Physician offices where office based surgery using sedation is performed must follow the standards set forth in the regulations which include requirements for administration, patient selection, sedation monitoring standards, equipment and space use and emergency transfers. California Health Safety Code, Ch. A.3, Sec. 1248; Bus. & Prof. Code, Secs , , 2240 Outpatient facilities Medical Board of California Licensure, Medicare certification or accreditation is required for all outpatient settings where anesthesia is used (excluding local or peripheral nerve blocks). The Division of Licensing has approved AAAHC, among others, as state-recognized accreditation agencies. The legislation also contains a number of other requirements such as those relating to liability insurance coverage, reporting complications, adequate personnel and written discharge criteria. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 1

2 STATE STATUTE/RULE ENTITY AGENCY DESCRIPTION California (continued) Facilities must be state licensed, Medicare-certified or accredited by an accrediting agency approved by the medical board in order to charge and collect a facility fee for use of the emergency room or operating room of the facility for services provided to injured employees under the state s workers compensation laws. Currently, the California Department of Public Health will not issue a license to clinics which have any percentage of physician ownership. Senate Bill 100 Governor Jerry Brown signed Senate Bill 100 into law. The law, which became effective on January 1, 2012, amends existing law requiring the accreditation of outpatient settings. Accreditation agencies are now required to query the Medical Board of California concerning any adverse accreditation decisions rendered against physician owners of an organization applying for accreditation. For outpatient settings that were not granted accreditation by another accrediting agency, the subsequent accreditation agency must determine that prior deficiencies were corrected. The law also requires the Medical Board to post on its website certain survey reports of accreditation agencies. At this time, the accrediting bodies are collecting information concerning physician owners; however, the Medical Board has not yet posted information online. Liposuction extraction and postoperative care standards for outpatient settings went in effect on Feb. 20, Procedures performed under general anesthesia or intravenous sedation, or that result in the extraction of 5,000 or more cubic centimeters of total aspirate, must be performed in a hospital or an outpatient setting that is licensed, or accredited by one of the approved entities listed above. SB 430 Business and Professions Code, Sec Dentists Dental Board On September 28, 2006, the Governor signed a bill into law which allows a person licensed to practice dentistry who is not a physician to apply for a permit to perform elective facial cosmetic surgery. The applicant would have to submit specified information to a credentialing committee appointed to the Board. The elective cosmetic surgery can only be performed in specified health facilities, including outpatient surgical facilities accredited by AAAHC. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 2

3 California (continued) Health and Safety Code, Sec Primary care clinics (community and free clinics which are subject to licensure) Services Effective Jan 1, 2004, primary care clinics (community and free clinics that provide a safety net for underserved, uninsured, and underinsured populations) that are accredited by AAAHC or other named accrediting organization are exempt from inspection by the Department. Colorado HB 1234 Colorado Revised Statutes, Ambulatory Surgical Centers Legislation enacted on May 27, 2008 recognizes accreditation by AAAHC as meeting certain licensing standards for renewals of ASC licenses. Policy Statement Office- based surgery and Anesthesia Board of Medical Examiners In Nov the Board adopted a policy statement regarding the provision of surgical and anesthesia services in office settings. Overnight patient stays are not recommended unless the facility is accredited as a Class B or C facility by AAAHC or other named accrediting organization, or Colorado Dept. of Public Health and the Environment. Connecticut Conn. Gen. Stats Sec. 19a- 691; HB 5531 (signed into law on June 3, 2004) Conn. Gen. Stats.19a-638 (a)(4); SB 1207 (signed into law on June 7, 2005) Outpatient surgery and offices where certain types of anesthesia are administered Office of Health Care Access, (OHCA) Dept. of Public Health Any office or unlicensed facility at which moderate sedation/analgesia, deep sedation/analgesia or general anesthesia is administered must be accredited by AAAHC, among other accrediting organizations, or be Medicare-certified, within 18 months of administering such sedation or anesthesia. A law effective July 1, 2004 requires a license and a certificate of need (CON) for non-hospital outpatient surgical facilities that use moderate sedation, deep sedation or general anesthesia. Medical offices are exempt if they do not administer deep sedation or general anesthesia and meet certain other conditions. Facilities that operated before July 1, 2003 or received an OHCA determination that a CON was not required may operate until March 30, 2007 without a license. Health care facilities OCHA A law, effective July 1, 2005, requires a certificate of need approval, regardless of cost, for any health care facility that purchases, acquires or accepts the donation of imaging and scanning equipment. The CON requirement will be waived if the equipment was acquired prior to July 1, 2005 or a CON or determination a CON was not required was obtained from OCHA before July 1, Delaware Freestanding surgical Health Resource Board (certificate of public review process) The Board requires AAAHC or accreditation by another accrediting organization within one year of licensure as a condition of approving new or converted freestanding ambulatory. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 3

4 District of Columbia DC Code Secs to Health care facilities including ambulatory surgical facilities Accreditation by a private accrediting body or certification to participate in a federal health program may be accepted in lieu of re-licensing inspection. Office-based facilities are subject to the licensing requirements as health facilities if complex procedures are performed. Office- based surgery Board of Medicine The Board issued an advisory in 2000 that it will follow ASA guidelines in determining the acceptable standard of care in cases involving office-based anesthesia. Florida Fla. Stats. Chapter 395; Fla. Admin. Code Sec. 59A Agency for Health Care Administration (AHCA) not accredited by AAAHC or another approved accrediting organization are subject to an annual licensure inspection survey. The agency accepts the survey report of an accrediting organization as substantial compliance. Fla. Stats. Sec (1), (3) ; (6); Fla. Admin. Code Rules 64B-9.009, , Office- based surgery performed in facility not regulated by AHCA or Board of Medicine; Florida law requires Dept. of Health inspections for physician office facilities where certain levels of surgery are performed, unless a nationally recognized accrediting agency or another accrediting organization subsequently approved by the Board of Medicine accredits the offices. Physicians performing certain levels of surgery in an office are required to register with the board and indicate whether their office is accredited or subject to a state inspection. The rules recognize AAAHC as an approved accrediting agency. The rules also require compliance with a number of state standards for office-based surgery. SB 2272 Pain Management Clinics Agency for Health Care Administration; Boards of Medicine and Osteopathic Medicine This bill, signed by the Governor on June 18, 2009, requires that certain clinics practicing pain management register with the and be subject to annual inspection or national accreditation. As of October 1, 2010, organizations subject to the law must register with the Agency for Health Care Administration. Fla. Stats. Sec HMOs and prepaid health clinics AHCA's Bureau of Managed Health Care HMOs and prepaid health plans are required to undergo an external quality assurance review by an approved accreditation organization, which includes AAAHC. Fla. Stats. Sec (11) (a); Fla. Admin. Code Rules 59A-33 Clinics providing MRI services Dept. of Health Clinics offering magnetic resonance imaging services must be accredited by AAAHC or another accrediting organization within one year after licensure, unless an extension is granted. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 4

5 Georgia Admin. Rules and Regs. of State of Georgia, Sec (1)(c )(10,11) facilities State Health Planning Agency The certificate of need licensing regulation requires that an applicant for an expanded ambulatory surgical facility, including diagnostic, treatment, or rehabilitation that offer ambulatory surgery, must provide appropriate documentation of meeting accreditation requirements of AAAHC, another named accrediting organization or other appropriate accrediting agency. An applicant for a new facility must provide a statement of intent to meet such accreditation requirements within one year of obtaining state licensure. Admin. Rules and Regs. of State of Georgia, Sec HMOs Office of Insurance and Safety Fire Commissioner In April 2005, AAAHC was recognized as an approved accrediting organization by the Office of Insurance and Safety Fire Commissioner. According to staff in the Commissioner s office, HMOs can seek certification under Georgia law through proof of accreditation by an approved accrediting organization only for an expansion of services. If the HMO is starting a new business in the state, it must go through the initial licensing procedure. Illinois Rules for the Administration of the Medical Practice Act of 1987, Sec Office- based anesthesia Department of Professional Regulation The Department has established minimum CME and ACLS certification requirements for operating physicians and anesthesiologists who administer certain levels of anesthesia in physician offices. In 2004, a court invalidated the rule requiring surgeons to have certain training and experience in anesthesia in order for a CRNA to provide anesthesia. Indiana 440 Ind. Admin. Code Sec. 4.1 Community mental health Division of Mental Health, Office of Contract Management, Licensing and Certification AAAHC is approved for accreditation of managed care providers of mental health and addiction services, including HMOs and university student health that provide health care services, including mental health. According to the Division, AAAHC does not have standards that focus strictly on mental health and therefore may not be applicable to stand-alone behavioral health organizations. Policy of Acute Care Div., Ind. State Dept. of Health, interpreting 410 Ind. Admin. Code Sec Ambulatory surgery Indiana State The Department accepts a Medicare deemed status survey conducted by AAAHC, or other accrediting organization with deemed status in lieu of its own annual re-licensing survey for the calendar year of that survey. 844 IAC 5-5 Office-based surgery Medical Licensing Board of Indiana After January 1, 2010, a practitioner may not perform or supervise a procedure that requires anesthesia in an office-based setting unless the practice is accredited by a Board approve accrediting organization such as AAAHC. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 5

6 Kansas Kan. Rev. Stats. Sec and other health care facilities and Environment The Department recognizes accreditation by entities defined in the state statute in lieu of its own licensing and risk management surveys. K.A.R Office- based surgery Kansas State Board of Healing Arts Regulations which set forth requirements for all office based surgery and procedures became effective January 1, In addition effective July 1, 2006, any physician who performs any office based surgery or procedure using general anesthesia or a spinal or epidural block must operate in an office that meets the standards of approved accrediting organizations, including AAAHC. Kan. Rev. Stats. Sec (b) HMOs Insurance Department A quality of care assessment by an independent organization is required for licensure of HMOs. AAAHC accreditation is recognized as meeting this requirement. Kentucky Guidelines for Office based Surgery Office- based surgery Board of Medical Licensure The Board adopted on Dec. 18, 2003 guidelines that reflect prevailing standards of care. Offices where Level II or III procedures are performed are expected to obtain accreditation by a named accrediting organization, including AAAHC. Registration, reporting of incidents, and liposuction limits were among the requirements approved. Louisiana Louisiana Administrative Code, Title 46, Ch. 73 Office- based surgery State Board of Medical Examiners The Board adopted regulations on office based surgery that took effect on Jan. 1, Exempt procedures include those requiring no anesthesia, local or topical anesthesia, regional anesthesia or conscious sedation, and procedures performed by an oral and maxillofacial surgeon within the dentistry scope of practice. Offices accredited by AAAHC, among other accrediting organizations, and licensed facilities, are exempt from the regulations. Maryland Mar. Rev. Stats. Sec. 19-3B-03 (d) Freestanding ambulatory care facilities and Mental Hygiene, Office of Health Care Quality Legislation, which became effective October 1, 2006, requires accrediting organizations to submit an application and enter into an agreement with the Department of Mental Health and Hygiene. Once approved, the accrediting organizations can perform licensing surveys of ambulatory care facilities on behalf of the Department. The new law also covers managed care organization licensing surveys. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 6

7 Massachusetts Senate Bill 2863, Gen. Laws, Chapter 111, Sec. 53G Clinics Legislation enacted on August 10, 2008 defines any entity which is certified or seeks certification as a Medicare ASC as a clinic for the purposes of licensure. Prior to the enactment of this legislation, certain physician owned entities could become Medicare certified ASCs without obtaining a license. Any such clinic which is accredited by AAAHC or another designated accrediting organization is deemed in compliance with the conditions for licensure as a clinic. Massachusetts Medical Society Guidelines for Office-Based Surgery Office- based surgery Mass. Medical Society; Board of Registration in Medicine The Board endorsed the medical society s guidelines, which are based on the level of anesthesia and the complexity of the procedures performed. In addition to other requirements, the recommendations provide that offices where surgery other than minor procedures are performed should be accredited by an accrediting organization, including AAAHC or AAOMS Office Anesthesia Evaluation program, or any other agency approved by the Board. Mississippi Mississippi State Board of Medical Licensure, Rules and Regulations, Article XXIV Office- based surgery State Board of Medical Licensure Depending on the level of surgery performed, the Board s requirements address surgeon registration, surgical logs and records, reporting of adverse incidents, equipment, supplies, and training of surgeons. The Board provides an alternative credentialing mechanism for procedures outside a physician s core curriculum. Strong recommendations are included for amount of fat to be removed using tumescent liposuction. Montana Mont. Code Sec ; SB 105 Outpatient for surgical services (not including physician offices) Department of Public Health and Human Services The Department may consider as eligible for licensure during the accreditation period any outpatient center for surgical services that furnishes written evidence of its accreditation by AAAHC or JCAHO. This is an alternative to inspections by the Department. Nebraska 175 Neb. Admin. Code, Ch. 7 and Human Services, Regulation and Licensure, Credentialing Division The Department deems ambulatory surgical accredited by AAAHC or JCAHO, or certified to participate in the Medicare or Medicaid program, to be in compliance with its standards of operation, care and treatment. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 7

8 Nevada AB NRS and NAC LCB File No. R facilities State Division of Health Dept. of Health and Human Services Health Division Bureau of Health Care Quality and Compliance Assembly Bill 123 mandates accreditation for licensed surgical. Centers must obtain accreditation by March 31, Newly licensed must submit proof of accreditation within six months of obtaining a license. AB 123 LCB File No. R Nevada Register of Reg. R179-09A Office based surgery State Board of Health Assembly Bill 123 also includes a requirement that physician offices which are not licensed as a medical facility obtain a permit prior to providing general anesthesia, conscious sedation or deep sedation. Permits must be obtained for each location. In addition, these offices must maintain accreditation by a nationally recognized accrediting organization recognized by the State Board of Health. Permits should have been obtained before October 1, The State Board of Health approved the AAAHC as an accrediting organization at its December 10, 2010 meeting. NAC Secs. 695C HMOs State Division of Health External quality examinations are required for HMO licensing. AAAHC accreditation is recognized as meeting this requirement. New Hampshire Laws of NH, Sec. 151:5-b; NHCAR (t) facilities and Human Services; Health Services Planning & Review Board Medicare-certified facilities are deemed licensed and are exempt from state inspections. Existing ambulatory surgical facilities may demonstrate the delivery of safe services by providing copies of accreditation survey reports. New Jersey NJAC 8:43A-3.12 (b) Ambulatory surgery and Senior Services After licensure, ASCs must submit annually the report of a survey by an independent accreditation organization whose standards meet or exceed Medicare conditions of coverage; however licensure is not conditional upon accreditation. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 8

9 New Jersey (continued) NJAC 13:35-4A.12; 17; Office- based surgery and anesthesia Board of Medical Examiners Regulations govern the administration of office-based anesthesia, including standards for training, credentialing, staffing, equipment and reporting. In Dec. 2002, the Board issued the final rule detailing the alternative privileging mechanism for office-based physicians who do not hold hospital privileges. Certain documentation of competence, training and clinical experience are required to obtain privileges for performing surgery or special procedures, performing or supervising general and regional anesthesia or conscious sedation, or utilizing lasers. The privileging requirement is not imposed for minor surgery although certain procedures such as liposuction and breast augmentation are not considered minor. Privileges are granted for two years. Initial applications must be submitted by Dec. 16, Physicians who submit an application for alternative privileging may continue to provide services until the Board acts on their application. The Board developed a list of acceptable in-office procedures and alternative privileging application forms, and selected an entity to review the documentation submitted along with application. N.J.A.C. 13: Office- based surgery Board of Medical Examiners Effective November 7, 2005, physicians who perform new or novel procedures in an office setting must establish procedural protocol that provides for the protection of patients consistent with settings under the jurisdiction of an Institutional Review Board which complies with the requirements of the Food and Drug Administration. In June 2005, the New Jersey Supreme Court upheld the Superior Court s ruling that the Board of Medical Examiners has the legal authority to impose supervision requirements on CRNAs working in physician s offices. A supervising physician without concurrent responsibilities must be present in the room when a CRNA administers general or regional anesthesia. These rules are the most restrictive of any state. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 9

10 New Jersey (continued) Senate Bill No. 787 Section 12 of P.L. 1971, C.136 Office-based surgery/surgical practice Dept. of Health and Senior Services Legislation was signed into law on March 21, 2009 which requires surgical practices to register with the Department of Health and Senior Services by March In addition, surgical practices must either obtain Medicare certification or accreditation from a CMS deemed accrediting body, including AAAHC, as a condition of registration. A surgical practice is defined as a structure or suite of rooms which has no more than one room for use as an operating room specifically designed for surgery, has dedicated recovery area and is established by a physician practice. The term also includes unlicensed entities which are currently Medicare certified. Also included in the legislation are additional requirements for registration. N.J.A.C. 8:43C Office-based/Surgical Practice and Senior Services Regulations effective as of January 12, 2012 require surgical practices in operation on January 17, 2012 to register with the Department or cease operation no later than April 16, Requirements for registration of surgical practices which had not commenced operation by January 17, 2012 were also included. Other requirements as set forth in the enabling legislation are also included. The Department has the authority to revoke, suspend of deny and application. Ambulatory care facilities Dept. of Health and Senior Services Ambulatory care facilities licensed to provide surgical and related services have one year from enactment to become accredited. New Mexico NM Statutes, Sec (F) Health facilities, including outpatient facilities and diagnostic and treatment, Health Facility Licensing and Certification Bureau Licensed health facilities that receive certification to participate in federal reimbursement programs and are fully accredited by entities defined in the statute are granted a license renewal based on that accreditation. New York NYCRR Title 10, Sec facilities ASCs must obtain accreditation from AAAHC or other named accrediting organizations within two full years of operation. After an initial licensing inspection, the Dept accepts accreditation surveys in lieu of its own re-licensing inspections. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 10

11 New York (continued) S New York State Public Health Law 230-d(1) Office- based surgery On July 18, 2007, the Governor signed into law legislation (S.6052) requiring that office-based surgeries be performed by physicians in settings that have obtained and maintained accreditation. Under the law, performing surgery in an unaccredited setting would constitute professional medical misconduct. In addition, the new law requires physicians in these practices to report adverse events, including patients who die within 30 days of a procedure, unplanned transfers to hospitals or other "serious or life-threatening" events, to the state Health Department's Patient Safety Center within 24 hours. Data from these reports is protected under the new legislation and will not be subject to public disclosure under state "freedom of information" act requests but can be included in reports that aggregate such outcome data. The accreditation requirement became effective July 14, AAAHC has been recognized by the as an approved accrediting organization. North Carolina 10 NC Admin. Code 03R.2116; 03R Sec. 2100; 03Q.0202(a) facilities Division of Facility Services, Department of Health and Human Resources Ambulatory surgery facilities (ASFs) are required to obtain accreditation from AAAHC or a comparable accreditation authority within two years of completion of the facility. ASFs accredited by AAAHC or other accrediting organizations are deemed as meeting licensure requirements. Position Statement on Office-Based Procedures Office-based Surgery North Carolina Medical Board On January 23, 2003, the Board approved a position statement of standards of practice. By January 2004, any physician performing level II or III procedures in an office should be able to demonstrate substantial compliance with the guidelines, or obtain accreditation by a nationally recognized agency such as AAAHC, or other board-approved agency. Other guidelines address physician credentialing, including an alternative privileging option, emergencies, performance improvement, medical records, patient selection, equipment and supplies and personnel. Failure to comply creates the risk of disciplinary action by the Board. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 11

12 Ohio Ohio Code Sec ; Admin. Code Sec facilities (ASFs). Surgical facilities holding themselves out to the public or government entities as ASFs are subject to the regulations. The Department accepts accreditation reports of ASFs in lieu of compliance with health facility regulations and an onsite state survey. The Department is authorized to renew a license without a state survey if the facility is accredited by AAAHC or other named accrediting organizations, and is deemed to be in compliance with the Medicare conditions of coverage. Compliance may also be demonstrated by an ASF that has achieved Medicare certification through a state survey that was conducted within 90 days of the licensure renewal date. Effective June 1, 2006, the Department adopted rules which, among other changes, increase penalties for operating without a license and failing to obtain informed consent from patients. The extent of the fine depends on factors, including whether there has been harm to the patient. Administrative Code Secs to 07 Office- based surgery State of Ohio Medical Board The Medical Board approved regulations requiring accreditation of offices where physicians or podiatrists perform surgery using moderate sedation or higher anesthesia. The rule took effect on January 1, Application is required within 18 months of that date and accreditation must be obtained within three years after that date. AAAHC, other named accrediting organizations and any other board-approved agencies are recognized. The rules also contain education, training and experience requirements for surgery and anesthesia, and limits on liposuction. Oklahoma Okl. Admin. Code Sec. 310: HMOs and prepaid health plans The Department examines the quality of health care services offered by HMOs and prepaid health plans, and has approved AAAHC as an independent quality examiner. Office- based surgery State Board of Medicine The Board adopted guidelines for physicians who perform procedures that require anesthesia or sedation in an office setting. Oregon ORS Sec (2); OAR Sec (2); Health care facilities including ambulatory surgical Dept. of Human Services, Oregon Health Division The Division may accept certificates by accreditation entities listed in the statute as evidence of compliance with acceptable standards in lieu of state inspections. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 12

13 Oregon (continued) Oregon Admin. Rules Sec to 006 Office-based surgery Oregon Board of Medical Examiners Regulations were adopted at the October 13, 2006 meeting of the Board which require that every physician performing procedures or surgery using conscious sedation or anesthesia services must perform them in a facility that is accredited by an agency approved by the Board. AAAHC is included as an approved accrediting agency. Oregon Admin. Rules Sec Dentists Board of Dentistry Dentists performing specified cosmetic surgery procedures deemed to be within the dentistry scope of practice must hold privileges issued by a credentialing committee of a JCAHOaccredited hospital, or of an ambulatory surgical center licensed by the state and accredited either by AAAHC or JCAHO. Pennsylvania Pa. Rules and Regulations, Title 28, Part IV, Subpart F, Chs facilities (includes physician offices with a distinct part used solely for surgery on a regular and organized basis) For Class A, limited to local or topical anesthesia, ASFs must register and obtain accreditation from a named accreditation organization, including AAAHC. For higher Classes B and C, licensure is required, although the rules allow the dept. to delegate the survey function to nationally recognized accreditation agencies. At this time, the Department is not recognizing accreditation for Class B or C licensure but conducts its own licensure surveys. Pa. Rules and Regulations, Title 28, Part I, Ch. 9 Rhode Island RI Stats., Ch Dept. of Health Rules and Regulations, R POSPST HMOs External quality review is required for licensure of HMOs. AAAHC accreditation has been recognized as meeting this requirement. The Department. revised its regulations and is expected to issue RFPs to approve external quality reviews organizations. Office- based surgery The Department issued regulations requiring licensure for offices in which surgery other than minor procedures is performed, along with other requirements. Physicians who provide such services must be licensed. Application for accreditation by an accrediting organization, including AAAHC, is required within nine months from initial licensure, with accreditation required within two years after licensure. Accreditation must be maintained as a condition of licensure thereafter. In June 2002, the enabling law was amended to specifically include office based podiatry. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 13

14 South Carolina Regulation 61-91, Sec. 202 facilities and Environmental Control The Department may consider accreditation surveys in determining the appropriateness of conducting its own inspections. Regulation Office- based surgery Board of Medical Examiners On June 7, 2007, the General Assembly ratified Regulation which requires accreditation of certain office-based surgery practices. The regulations define three levels of practice and requirements are based on the level of practice. Tennessee Tenn. Code Sec (b)(5)(a) Licensed health care facilities accredited by a federally recognized accrediting body are deemed to meet all applicable licensing requirements. Rule Office-based surgery Tennessee Board of Medical Examiners The Board adopted new regulations in October, 2007 following legislation which directed the Board to use the rules for ambulatory surgical treatment guidelines for regulations. These regulations are intended to apply to physician s who perform Level I, II, IIA and III surgeries as part of a medical practice whose focus in on the provision of medical services and procedures not related to surgery an option to provide on-site surgical services. Other practices must comply with the laws governing ambulatory surgical treatment. For Level I and II office- based surgery practices, the rule sets forth requirements. For Level III office- based surgery, the physician must apply for certification from the Board. H.B Public Chapter No. 373 Office-based surgery The Department of Health Legislation has been enacted which requires the Board to use the rules for ambulatory surgical treatment as guidelines for establishing rules regarding infection control, life safety, patients rights, hazardous waste, and equipment and supplies. The is required to provide a site survey of the physician s office, conduct subsequent unannounced visits and respond to patient complaints. The results of these surveys will be forwarded to the Board, subject to certain confidentiality restrictions. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 14

15 Texas 25 Texas Admin. Code Sec ; Department of State Health Services Effective April 4, 2004, an initial or renewal state licensing survey may be waived if the ASC provides documented evidence of accreditation by AAAHC or another accrediting organization and Medicare deemed status. The Executive Commissioner of the Health and Human Services Commission has adopted amendments to the regulations governing ASCs that include new requirements for the governing body to adopt policies relating to accurate billing, evaluation of nutritional needs of patients staying for over 8 hours and establishment of an emergency call system. In addition, the regulations amend requirements for anesthesia, surgical and nursing services and reporting requirements. Tex. Civ. Stats. Article 4495b, Subch, G, Secs ; Article 4427e 22 TAC Sec ; Outpatient surgical settings that are not part of a licensed hospital or ambulatory surgical center State Board of Medical Examiners; State Board of Nursing Examiners The two Boards adopted regulations governing physicians and CRNAs providing or administering general or regional anesthesia, or monitored anesthesia, in outpatient settings. The regulations exempt licensed ASCs and outpatient settings accredited by accreditation organizations, including, AAAHC. 22 TAC Sec SB 155 Health benefit plans including HMOs Department of Insurance Legislation enacted on June 17, 2005 deems HMOs and other health benefit plans that are accredited by nationally recognized accreditation organizations, including AAAHC, from state regulatory requirements. Utah Dept. of Health, Health Facility Licensure, #R Surgery, treatment, and birthing, behavioral health clinics and home care facilities The Department s regulations recognize accreditation by AAAHC, Community Health Accreditation Program, among others, for deemed status for health care facilities requiring licensure. In February 2004, the Department approved AAAHC to perform independent audits of ASCs' patient safety programs for identifying and reporting adverse drug events. Virginia 12 VAC Ambulatory surgery Code of Va.., Sec Department of Professional. & Occupational. Regulation The Certificate of Public Need regulations require ASCs to meet applicable standards of AAAHC or other named accrediting organization. Podiatrists may not perform surgery under a general anesthetic in an ambulatory surgery center unless it is approved by AAAHC or another accrediting organization. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 15

16 Virginia (continued) 18 VAC to 390 Ambulatory surgery and office- based surgery Board of Medicine The Board issued regulations governing office-based anesthesia, effective June 18, The regulations cover doctors of medicine, osteopathic medicine and podiatry in non-hospital settings where moderate sedation or higher levels are administered, and include training, transfers, reporting and other requirements. Washington Wash. Admin. Code Sec B-0100 Ambulatory surgery that contract with Dept. of Labor and Industries Department of Labor and Industries ASCs that contract with the Department to provide medical services to injured workers and crime victims must have either Medicare certification or accreditation by a nationally recognized agency acknowledged by CMS. Wash. Admin. Code Sec Ambulatory surgery Legislation enacted on May 2, 2007, requires ambulatory surgical facilities to be licensed. Previously, while certain facilities had to obtain a certificate of need, there was no license requirement. A facility may demonstrate it has met the licensing standards if it is Medicare certified or has met the standards of an accrediting organization with substantially equivalent standards. After June 30, 2009, all ambulatory surgical facilities must be licensed. Whether or not an organization is accredited, the facility must be surveyed every 18 months by the Department of Health. The is currently only issuing licenses to organizations which use general anesthesia. Offices maintained for the practice of dentistry and outpatient specialty or multi-specialty surgical services routinely performed in the office of a practitioner in an individual or group practice not requiring general anesthesia are exempt from the licensing requirements. The legislation also includes adverse event reporting requirements as well as numerous other conditions. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 16

17 Washington (continued) HB 1414 (Continued) WAC Office-based surgery Medical Quality Assurance Commission The rules apply to physicians who practice independently or in a group and perform office based surgery using moderate sedation or analgesia, deep sedation or analgesia or major conduction anesthesia. There are exemptions to the rule including surgery performed in licensed facilities and oral and maxillofacial procedures so long as the physician performing the surgery is licensed as both a physician and dentist and is in compliance with the Washington State Dental Assurance Commission regulations, including the holding of the appropriate anesthesia permit. Within 365 days of the effective date of the rule (September 2, 2011), physicians must perform surgery in an organization that is accredited by an approved accrediting organization which includes AAAHC or is a Medicare certified organization. In addition, the rules contain requirements addressing physician competency in anesthesia, the separation of surgical and monitoring functions, emergency care and transfer protocols and medical records. Wyoming Wym. Stats. Sec (a) Ambulatory surgery Licensed health care facilities accredited by a nationally recognized accrediting body approved by federal regulations are granted a license renewal without further inspection by the department. Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 17

18 REGULATIONS IN DEVELOPMENTAL OR DRAFTING STAGE STATE STATUTE/RULE ENTITY AGENCY DESCRIPTION Florida SB 2272 Pain Management Clinics Florida Boards of Medicine and Osteopathic Medicine The Florida Boards of Medicine and Osteopathic Medicine were conducting rulemaking pursuant to SB462. This bill, signed by the Governor on June 18, 2009, requires that certain clinics practicing pain management register with the and be subject to annual inspection or national accreditation. Both Boards are required by the bill to adopt rules setting forth standards for physicians practicing in registered pain management clinics. As of October 1, 2010, organizations subject to the law must register with the Agency for Health Care Administration. The Boards of Medicine and the Osteopathic Medicine Pain Management Clinic Standards of Practice Joint Committee has issued draft rules for the approval of national accrediting organizations, but no accrediting organizations have been approved at this time. Twenty seven states and DC require or recognize accreditation of certain types of ambulatory surgical or facilities (AZ, CA, CO, DE, DC, FL, GA, IN, KS, MD, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA and WY). For office-based surgery procedures meeting various thresholds, Connecticut, Indiana, Ohio, Nevada, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, South Carolina and Washington State require accreditation. Kansas requires that practices meet the requirements of accreditation. California and Florida require state certification or accreditation. Louisiana, North Carolina and Texas exempt accredited settings from surgery/anesthesia regulations or guidelines. Alabama, Illinois, Mississippi, New Jersey and Virginia adopted office anesthesia or surgery regulations. Colorado, D.C., Kentucky, Massachusetts, North Carolina and, Oklahoma adopted voluntary guidelines or policy statements. The Arizona Medical Board and the Tennessee Board of Medical Examiners have adopted regulations specifying further requirements for office based practices, but not accreditation. Seven states recognize AAAHC accreditation for quality assurance reviews of HMOs (Florida, Georgia, Kansas, Oklahoma, Pennsylvania, Nevada and Texas). Wisconsin recognizes AAAHC accreditation for Medicaid managed care plans. This information was compiled from a variety of sources, including NCSL, AMA, medical specialty societies, regulators and accreditation organizations. AAAHC cannot guarantee its complete accuracy, and continues to research state statutes and rules governing ambulatory health care. Please report any changes or new information to Carolyn Kurtz, AAAHC General Counsel & Vice President, Government / Public Affairs (TEL: 847/ ). Thank you for your assistance. States/ambulatory state regulation Ambulatory Regulations, Accreditation Association for Ambulatory Health Care, Page 18